雷帕霉素药物支架释放度测定  

Release test of rapamycin in drug-eluting stents

作　　者：章娜[1] 冯晓明[1] 陈华[1] 

机构地区：[1]中国药品生物制品检定所医疗器械检测中心,北京100050

出　　处：《药物分析杂志》2010年第7期1385-1388,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立一种雷帕霉素冠脉药物支架体外释放度测定的方法。方法：根据美国药典释放度测定第7法的仪器装置,改装了药物溶出度仪。释放介质为4%牛血清和0.1%叠氮化钠溶解在PBS（pH=7.4,0.01 M）的缓冲液;以ODS为固定相,乙腈∶水（65∶35）为流动相,柱温为60℃,检测波长为280 nm。结果：雷帕霉素在0.5-100μg·mL^-1浓度范围内线性关系良好,相关系数0.9999,回收率99.7%,最低检测限为0.025μg;雷帕霉素在0-28 d的释放曲线与USP释放度测定第7法测定结果一致。结论：本法改装后的仪器简便,适合国情,符合USP7的要求,检测结果较为满意。Objective：To establish a method for the analysis of release of rapamycin in drug eluting stents（DES）.Methods：Chp dissolution test method（modify USP7）was adopted and used 250 mL the mixture of 4% BSA and 0.1%NaN3 in PBS buffer（pH=7.4,0.01 M）as the release media.Agilent Ecilpse C18（150 mm×4.6 mm,5 μm）was adopted,The mobile phase consisted of acetonitrile and methanol solution（65∶35）at a flow rate of 1.0 mL·min^-1.Keep the detective wave length at 280 nm.Results：The linear correlation of rapamycin in acetonitrile is observed over the range of 1-100 μg· mL^-1（r=0.9999）.The recoveries of rapamycin is 99.7%.The LOD is 0.025 μg.The release of rapamycin using improved method is identical to which using USP method Ⅶ.Conclusion：The method is fastness and convenience.

关 键 词：释放度 药物支架 雷帕霉素 

分 类 号：R917[医药卫生—药物分析学]